(185 days)
No reference devices were used in this submission
No
The document describes a physical implant (spacer system) made of PEEK and titanium, intended for spinal fusion. There is no mention of software, algorithms, data processing, or any other components that would suggest the use of AI or ML. The performance data section focuses on mechanical testing and clinical outcomes of the physical device.
Yes.
The device is intended for spinal fusion procedures to treat degenerative disc disease, restore biomechanical integrity, and treat fractures, which are medical treatments for conditions.
No
This device is an implant used for spinal fusion procedures, not for diagnosing conditions.
No
The device description clearly states the device is comprised of physical implants made from PEEK and titanium, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System are described as implants used in spinal fusion procedures and partial vertebral body replacement. They are physical devices implanted into the body to provide structural support and facilitate fusion.
- Lack of Diagnostic Activity: The text does not mention any testing of biological samples or any diagnostic function of the device. Its purpose is entirely therapeutic and structural.
Therefore, the CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System are medical devices, but they fall under the category of implantable surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
CONSTRUX Mini PEEK Spacer System
When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PEEK Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.
When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial replaced vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mimi PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.
The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.
CONSTRUX Mini PEEK Ti Spacer System
The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MQP
Device Description
CONSTRUX Mini PEEK Spacer System: The CONSTRUX Mini PEEK Spacer System is comprised of a variety of implants manufactured from PEEK and with titanium markers. The implants are available in two footprint sizes, a small and a large. The implants are available in various heights, in onemillimeter increments. The superior and inferior surfaces of the implant have a pattern of ridges to provide increased stability and help prevent anterior/posterior movement of the device.
CONSTRUX Mini PEEK Ti Spacer System: The CONSTRUX Mini PEEK Ti Spacer System is comprised of a variety of implants that has a PEEK core with integrated porous Titanium end plates. The superior and inferior Titanium plate surfaces of the implant provide increased stability for the implant. The implants are available in three footprint sizes and various heights. The CONSTRUX Mini PEEK Ti spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1), thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
The purpose of this 510(k) submission is to seek clearance to allow one or two contiguous levels use for the CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System implants in the cervical spine. No changes have been made to the actual implants and therefore no mechanical testing was performed to help determine substantial equivalence.
PERFORMANCE DATA - Summary of Clinical Test Conducted for Determination of Substantial Equivalence
Published clinical data for the cervical interbody fusion devices similar to the CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System, implants was provided in support of this application. The published clinical outcomes demonstrated that the use of PEEK interbody devices for one or two contiguous levels in anterior cervical fusion procedures, as defined above, poses no new or additional risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional clinical testing was required or performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three faces overlapping to represent the department's focus on people and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2015
Orthofix, Incorporated Natalia Volosen Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K150619
Trade/Device Name: CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: August 12, 2015 Received: August 14, 2015
Dear Ms. Volosen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
page 1 of 2
510(k) Number (if known) K150619
Device Name
CONSTRUX Mini PEEK Spacer System CONSTRUX Mini PEEK Ti Spacer System
Indications for Use (Describe)
CONSTRUX Mini PEEK Spacer System
When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PEEK Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.
When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial replaced vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mimi PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.
The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.
CONSTRUX Mini PEEK Ti Spacer System
The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/4/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. The "®" symbol is located to the right of the word "ORTHOFIX".
510(k) SUMMARY
PEEK Cervical Interbody Devices
| 510(k) Owner Information
Name:
Address: | Orthofix Inc.
3451 Plano Parkway
Lewisville, TX 75056 |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Fax Number:
Email: | 214.937.2145
214-937-3322
nataliavolosen@orthofix.com |
| Registration Number: | 3008524126 |
| Contact Person: | Natalia Volosen
Senior Regulatory Affairs Specialist |
| Date Prepared: | September 3, 2015 |
| Name of Device
Trade Name / Proprietary
Name: | CONSTRUX Mini PEEK Spacer System
CONSTRUX Mini PEEK Ti Spacer System |
| Common Name: | Intervertebral body fusion device
Spinal intervertebral body fixation orthosis |
| Product Code: | ODP, MQP |
| Regulatory Classification: | Class II per 21 CFR § 888.3080
Class II per 21 CFR § 888.3060 |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | K142264 - Valeo Spacer System, SE 12/8/2014, Amedica
Corporation (primary predicate device)
K142152 – CONSTRUX Mini PEEK Spacer System and
CONSTRUX Mini PEEK Ti Spacer System (additional
predicate)
No reference devices were used in this submission |
| Reason for 510(k) Submission:
Expanded Indications for Use | |
Device Description
CONSTRUX Mini PEEK Spacer System:
The CONSTRUX Mini PEEK Spacer System is comprised of a variety of implants manufactured from PEEK and with titanium markers. The implants are available in two footprint sizes, a small and a large. The implants are available in various heights, in onemillimeter increments. The superior and inferior surfaces of the implant have a pattern of
5
ridges to provide increased stability and help prevent anterior/posterior movement of the device.
CONSTRUX Mini PEEK Ti Spacer System:
The CONSTRUX Mini PEEK Ti Spacer System is comprised of a variety of implants that has a PEEK core with integrated porous Titanium end plates. The superior and inferior Titanium plate surfaces of the implant provide increased stability for the implant. The implants are available in three footprint sizes and various heights. The CONSTRUX Mini PEEK Ti spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.
Intended Use / Indications for Use
CONSTRUX Mini PEEK Spacer System
When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PEEK Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.
When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.
The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.
CONSTRUX Mini PEEK Ti Spacer System
The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of
6
Image /page/6/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in bold, black letters. The "R" in "ORTHOFIX" has a registered trademark symbol next to it.
discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The CONSTRUX Mini PEEK Spacer system and CONSTRUX Mini PEEK Ti Spacer system has the same intended use, similar indications for use, similar technological characteristics and design, similar materials and the same principles of operation as the Amedica Valeo Spacer System (K142264).
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
The purpose of this 510(k) submission is to seek clearance to allow one or two contiguous levels use for the CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System implants in the cervical spine. No changes have been made to the actual implants and therefore no mechanical testing was performed to help determine substantial equivalence.
PERFORMANCE DATA - Summary of Clinical Test Conducted for Determination of Substantial Equivalence
Published clinical data for the cervical interbody fusion devices similar to the CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System, implants was provided in support of this application. The published clinical outcomes demonstrated that the use of PEEK interbody devices for one or two contiguous levels in anterior cervical fusion procedures, as defined above, poses no new or additional risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional clinical testing was required or performed.
Basis of Substantial Equivalence
The CONSTRUX Mini PEEK Spacer system and CONSTRUX Mini PEEK Ti Spacer system has the same intended use, similar indications for use, similar technological characteristics and design, similar materials and the same principles of operation as the Amedica Valeo Spacer System (K142264). The minor differences between CONSTRUX Mini PEEK Spacer system and CONSTRUX Mini PEEK Ti Spacer system implant design and the Amedica Valeo Spacer System (K142264) predicate does not introduce any additional patient risk.
No design changes have been made to CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System since their last 510(k) clearance K142152, SE 1/8/2015. The purpose of this 510(k) submission is to seek clearance to allow one or
7
Image /page/7/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. There is a registered trademark symbol after the word "ORTHOFIX".
two contiguous levels use for the CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System implants in the cervical spine.